“Your firm is marketing unapproved drugs,” the U.S. Food and Drug Administration wrote. “They are not generally recognized as safe and effective for their labeled uses.”

The FDA cited several cold medicines that Sovereign has manufactured for business partner Capellon Pharmaceuticals, including Certuss, Trexbrom, Tekral, Rescon and Liquibid. Additionally, the variety of Rescon pictured here “is missing important warning information” that should tell people not to use it under certain conditions “unless directed by a doctor.”

Sovereign also committed “significant violations of current good manufacturing practice” when making the anti-spasm prescription drug Symax, the FDA said. Further, Sovereign failed to test “for adequacy of mixing to ensure uniformity” among tablets of the widely used prescription painkiller hydrocodone.

Sovereign officials would not speak with me. Their website says the company “maintains an excellent relationship with the FDA” and other government agencies while strictly adhering to safety regulations.

The FDA previously sent warning letters to Sovereign at least twice — for marketing unapproved drugs in 2002, and for manufacturing failures in 1998.

Sovereign’s offices are near Capellon’s in a northeast Fort Worth warehouse district. FDA records identify Capellon’s chairman, Ralph Brown, and president, David Brown, as the co-owners of Sovereign.

“You should take prompt action to correct the violations,” the FDA told the Browns in the recent warning letter, dated Jan. 29. “Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.”

Ronald Woody, who ran one of the pharmacies and now faces possible discipline by regulators, told me in the above-linked Dallas Morning News story that he did all required paperwork. So how was it, I asked, that pharmacy technicians made off with so much hydrocodone and diazepam (better known as Valium)?

“They were just clever thieves,” Woody said.

Any other answers, anyone? Send me an e-mail or join the conversation by commenting below.